BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCOLADE (127 DEG) SIZE 4.5 ACCOLADE (127 DEG) SIZE 4.5

    MDR report key: 7406240 · Received April 9, 2018

    Report

    Report Number
    0002249697-2018-01053
    Event Type
    Injury
    Date Received
    April 9, 2018
    Date of Event
    March 14, 2018
    Report Date
    May 29, 2018
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    PMA / PMN Number
    K121308
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVENT REGARDING DISASSOCIATION INVOLVING AN ACCOLADE STEM WAS REPORTED. THE EVENT WAS CONFIRMED. METHOD & RESULTS: -PRODUCT EVALUATION AND RESULTS: VISUAL INSPECTION: A VISUAL INSPECTION WAS CARRIED OUT AS PART OF THE MATERIAL ANALYSIS REPORT. THE FOLLOWING WAS NOTED: SCRATCHES AND DAMAGES CONSISTENT WITH THE EXPLANTATION PROCESS WERE OBSERVED ON THE FEMORAL HEAD. THE FEMALE TAPER ON THE DISTAL SURFACE SHOWED SIGNS OF WEAR AND ADHERED DEBRIS. THE WEAR OBSERVED ON THE HIP STEM AND THE FEMORAL HEAD TAPER WAS LIKELY DUE TO THE LOSS OF TAPER LOCK BETWEEN THE STEM TRUNNION AND THE FEMORAL HEAD TAPER. THE LOOSENING LIKELY CAUSED THE STEM TO ARTICULATE WITH THE HEAD CAUSING WEAR DAMAGES. THE MATERIAL ANALYSIS REPORT (MAR) CONCLUDED THE FOLLOWING: THE WEAR OBSERVED ON THE HIP STEM TRUNNION AND FEMORAL HEAD TAPER WAS CONSISTENT WITH A LOSS OF TAPER LOCK BETWEEN THE FEMORAL HEAD AND THE HIP STEM TRUNNION. EDS SHOWED THAT THE HIP STEM WAS CONSISTENT WITH ASTM F1813 AND THE FEMORAL HEAD WAS CONSISTENT WITH ASTM F1537. EDS ALSO SHOWED THAT THE ADHERED DEBRIS ON THE HIP STEM AND FEMORAL HEAD IS CONSISTENT WITH MATERIAL TRANSFER. BASED ON THE GIVEN INFORMATION, NO IDENTIFIABLE MATERIAL DISCREPANCIES WERE OBSERVED ON THE SURFACES EXAMINED. -MEDICAL RECORDS RECEIVED AND EVALUATION: A REVIEW OF THE PROVIDED MEDICAL RECORDS AND/OR X-RAYS BY A CLINICAL CONSULTANT INDICATED: NARRATIVE PATIENT HAD PREVIOUSLY UNDERGONE A PRESSFIT THA. AN UNDATED XRAY TAKEN PRIOR TO REVISION SURGERY SHOWS THE FEMORAL HEAD DISASSOCIATED FROM THE TRUNNION OF THE FEMORAL STEM. THERE IS OBVIOUS REMODELING OF THE TRUNNION WITH LOSS OF MATERIAL. THESE FINDINGS WERE CONFIRMED BY THE MATERIAL ANALYSIS PERFORMED AND WERE FELT TO BE CAUSED BY LOSS OF TAPERLOCK BETWEEN THE STEM TRUNNION AND FEMORAL HEAD TAPER. THE LOOSENING LIKELY CAUSED THE STEM TO ARTICULATE WITH THE HEAD CAUSING WEAR DAMAGES. ASSESSMENT: THE PRIMARY HARM INVOLVED IS DISASSOCIATION THA FEMORAL HEAD FROM FEMORAL STEM CAUSED BY LOSS OF TAPER LOCK BETWEEN THE STEM TRUNNION AND FEMORAL HEAD TAPER. -PRODUCT HISTORY REVIEW: A REVIEW OF THE DEVICE MANUFACTURING RECORDS INDICATE THAT ALL DEVICES ACCEPTED INTO FINAL STOCK WERE FREE FROM DISCREPANCIES. -COMPLAINT HISTORY REVIEW: THERE WERE NO OTHER EVENTS FOR THE LOT PROVIDED. CONCLUSIONS: THE MEDICAL REVIEW CONCLUDED: ASSESSMENT: THE PRIMARY HARM INVOLVED IS DISASSOCIATION THA FEMORAL HEAD FROM FEMORAL STEM CAUSED BY LOSS OF TAPERLOCK BETWEEN THE STEM TRUNNION AND FEMORAL HEAD TAPER. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOME AVAILABLE TO INDICATE FURTHER EVALUATION IS WARRANTED, THIS RECORD WILL BE REOPENED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT'S RIGHT HIP WAS REVISED DUE TO DISASSOCIATION OF THE HEAD FROM THE STEM. THE CUP WAS REPORTED WELL-FIXED AND REMAINED IN THE PATIENT.

    Additional Manufacturer Narrative · 1

    REVIEW OF THE DEVICE HISTORY RECORDS INDICATE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THERE HAVE BEEN NO OTHER EVENTS FOR THE LOT REFERENCED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT'S RIGHT HIP WAS REVISED DUE TO DISASSOCIATION OF THE HEAD FROM THE STEM. THE CUP WAS REPORTED WELL-FIXED AND REMAINED IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252518 ACCOLADE (127 DEG) SIZE 4.5 ACCOLADE (127 DEG) SIZE 4.5 PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED LPH STRYKER ORTHOPAEDICS-MAHWAH 35653703

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| R